drugset / Trial / NCT03302585

High-Dose Vitamin D Induction in Optic Neuritis

NCT03302585

Phase 2 Terminated 12 enrolled University of Calgary
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a phase II randomized double-blind placebo/standard of care trial to determine if rapidly inducing vitamin D sufficiency in patients with acute optic neuritis results in less damage/greater recovery at 12 months as measured by optical coherence tomography, visual evoked potentials, visual acuity and radiological measures. Our hypothesis, based on earlier observational studies, is that acute optic neuritis in the context of vitamin D sufficiency results in better visual outcomes compared to those that are not sufficient acutely, regardless of such interventions as steroid therapy.

Timeline

Start
2017-11-23
Primary completion
2024-05-09
Completion
2024-05-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Cholecalciferol Other / unclassified 4000 iu Oral
Subject Cholecalciferol Other / unclassified 10000 iu Oral

Indications